Hermostatic clasp



Oct. 17, 1967 J. w. CODLING 3,347,239

HEMOSTATIC CLASP Filed July 13, 1964 lNC/SED ARE-A 0F CERV/X 1N VENTOR. JOHN W COOL/N6 A TTO/Q NE Y6 United States Patent 3,347,239 HERMOSTATIC CLASP John W. Codling, 700 Broadway, Seattle, Wash. 98122 Filed July 13, 1964, Ser. No. 382,079 4 Claims. (Cl. 128-325) This invention relates to a hemostatic clasp, and more particularly to a surgical clip useful to arrest cervical hemorrhage, which clip is of the type subject to struc tural deterioration in situ at a rate predetermined to insure release of the gripping action upon .the passage of a preselected time as disclosed in co-pending application Ser. No. 475,458 (July 28, 1965) filed jointly by John W. Codling and John W. Sweet as a continuation-in-part of applications Ser. No. 292,046, filed July 1, 1963, and

Ser. No. 382,079, filed July 13, 1964.

It is now recognized as an important therapeutic procedure to practice surgical conization of the uterine cervix. For example, surgical conization is widely used in obtaining biopsy specimens for the determination of the presence of carcinoma. The conization technique produces an annular, incised surface, roughly conical in shape, on the inner lips of a cervix, which area cuts across numerous blood vessels, particularly two rather large vessels extremely difiicult to suture. A difficulty accompanying such surgery is the arresting of post-operative hemorrhaging of several blood vessels. Cauterization, in part, is employed, as also is sutering by well known techniques. Mowever, cauterization and/or sutering is extremely complicated in connection with cervical conization, is timeconsuming, and can be less than satisfactory in arresting hemorrhage.

According to the present invention, a plurality of surgical clasps is applied to the cervix by use of a surgical clamp, similar structurally to a well-known hemostat or a Kocher clamp, first in the 3-, 6-, 9- and l2-oclock positions and then, preferably, in the intermediate positions. In such a use of these surgical clasps, approximately eight would thus be applied, although it will be apparent that, depending upon the size of the cervix, the shape of the incised area, and other variables, more or less of these surgical clasps would be used. The clasps are shaped and proportioned to permit their close side-by-side application to insure substantially uniform annular arresting pressure over substantially the entire incised area. In general, the clasps are characterized by having one of a pair of jaws tapered in width towards the gripping end and the other of the pair divergent in width towards the gripping end so that the clamp generally presses on a segment of the annular incised area and, together with a plurality of like clamps is capable of providing effective hemostasis of the entire area.

It is desirable in the application of hemorrhage-arresting pressure that such pres-sure be applied not only evenly, but only so long as necessary and no longer, to avoid deterioration of the cervical tissue by pressure necrosis. To that end the novel clamp form of this invention provides for automatic self-release at a predetermined rate and time by reason of structural failure thereof in situ under the effect and influence of body fluids, preferably according to the principles as disclosed and claimed in said co-pending application Ser. No. 475,458, filed July 28, 1965, in the joint names of John W. Codling and John W. Sweet. Thus, a safety factor is provided against the event that the patient does not present herself for post-operative examination and the surgeons removal of the clasps as conditions dictate. Thus each clasp has a pair of jaw members formed of a substance preferably subject to galvanic action protected at all except a restricted area from such action by a metallic substance less responsive to the effects and action occurring in the 3,347,239 Patented Oct. 17, 1967 presence of body fluids. In short, the base metal from which the jaws are formed is a sacrificial metal, subject to galvanic corrosion and disintegration in the presence of an electrolyte, preferably at the hinge point of the jaws where this sacrificial metal is exposed. Elsewhere it is protected by a coating of metal of a higher order of nobility in the electromotive series which is, in the environment, non-corrosive or at least markedly less corrosive than the base metal, and is non-irritating to human tissue.

In the following specification, the invention is described as to the maner and process of making and using it so as to enable any person skilled in the pertinent arts to practice the same. The best mode contemplated at the present for carrying out the invention is set forth in the specification which follows, reference therein being made to the accompanying drawings showing the invention and modifications thereof, in which:

FIGURE 1 is a perspective view of a surgical clasp according to the instant invention;

FIGURE 2 is a plan view of the clasp of FIGURE 1;

FIGURE 3 is a View in side elevation of a modified clasp in which the tapered jaw is longer than the flared J FIGURE 4 is a cross-sectional view taken on lines 4-4 of FIGURE 3;

FIGURE 5 is an enlarged fragmentary view of the side of the clasp hinge representative of either preceding embodiment;

FIGURE 6 is a plan view of another modified form of clasp;

FIGURE 7 is a cross-section taken on line 77 of FIGURE 6; and

FIGURE 8 is a diagrammatic face view of a conized cervix with a few surgical clasps in hemorrhage-arresting position.

In essence as disclosed herein, this surgical clasp comprises a U-shaped, metallic body providing a pair of opposed jaws adapted to engage and grip tissue. Preferably gripping teeth are formed at the outer extremities of the jaws. The body is formed of a malleable metal desirably selected from the group consisting of aluminum and aluminum alloys, e.g., a metal of a low order of nobility in the electromotive series. This body is coated with a metal chosen from the group of a relatively high order of nobility in the electromotive series. The body coating material is interrupted in a restricted area on the clasp body preferably adjacent the bend or hinge point of said U-shaped body. Such interruption exposes the body material. When the clasps are applied to the cervix or elsewhere in the body, in the presence of the body fluid which is an electrolyte, a galvanic action takes place causing deterioration of the exposed clasp body material. By governing the amount of exposure and by selecting a body material either more or less subject to such deterioration or of thicknesses that more or less rapidly are deteriorated, the rate of deterioration can be predetermined and the effective life of the olasp can be preselected. Preferably the coating materials are exemplified as being one of those selected from the group consisting of gold, silver or platinum. They are applied by well-known electro-plating techniques. Such metal surfaces resist body fluid action and restrictabsorption of the base metal of the clasps. These and other aspects of the self-release and protective functions of the clamp are explained more fully in said co-pending application.

Referring to FIGURES l and 2, the novel clasp is shown in one form as comprising a tapered first jaw '10 and a somewhat longer flared or spatulate second jaw 12 integrally joined with each other by a hinge bend 14. Jaw 10 generally tapers from the bend 14 to a narrow end having a single tooth or prong 16. Conversely, jaw 12 flares from bend 14 and is provided with a pair of spacedapart teeth or prongs 18, 18. As shown, teeth 18 straddle tooth 16. The edges of jaw are provided with flanges 11 which serve to stiffen the jaw. A concavo-convex dimple in either or both jaws provides for engagement of the jaw 10 by means of a speculum of conventional design. Likewise, jaw 12 has flanges 13 for the same purpose. It is desirable that the opposed or facing surfaces of jaws 10 and 12 be smooth and substantially planar with their respective flanges curving smoothly therefrom. In the modification of FIGURES 3 and 4 tapered jaw 10 is made longer than flared jaw 12, but the two embodiments as thus far described are or may otherwise be similar. As shown in FIGURES 3 and 5, the bend or gullet 14 of either embodiment desirably has a uniform crosssection that is unflanged and is readily bent to close the jaws together in a gripping action. Flanges on the outer edges of the jaws stiffen them and facilitate their being gripped during application.

Following the stamping and shaping of the clasps from a malleable aluminum or aluminum alloy, they are subjected to an electroplating operation in which they are fully coated with a metal of a higher electromotive nobility, e.g., gold, silver or platinum. Subsequently, as explained in said co-pending application, the plating is interrupted as at point and/ or point 21 of the hinging bend 14. This interruption removes a portion of the plating material and exposes the underlying base material to attack by body fluids while providing the desirable two-metal system. This interruption of the coating may be accomplished by grinding, filing or scratching through the plating. Or a series of perforations may be made through the coating to expose the base metal on either or bore surfaces of bend 14. The amount of exposure may vary from a hair line scratch at the clasp gul-let to a fairly obvious and relatively large exposed area. At such time, the thickness of the hinge bend 14 may also be materially reduced. In this manner, the rate of disintegration under galvanic action may be varied while at the same time sufiicient structural integrity of the clasp is maintained for the hemorrhage-arresting purposes. Strangely, the rate of deterioration of the base metal is more rapid when the interruption is a hair-line scratch as compared with a broader interruption such as would be made by a flat-filed cut.

In FIGURES 6 and 7 is shown still another form of clasp modified in that the tapered or triangular jaw is provided on its back side with a loop defining a hollow passage 31 into which a jaw of a speculum may be inserted for applying or removing the clasp. law 32 may likewise have such a retainer loop. It will be noted in FIGURE 1 that prong 16 generally may be engaged in tissue that is less distant from the hinge bend 14 than are the s-paced apart prongs 18 on the spatulate or flared jaw 12. The converse is the case with the embodiments of FIGURE 3 and FIGURE 6. Thus the inward reach of jaw 30 (FIGURE 6) into the cervix is preferably greater than that of jaw 10 (FIGURE 1) as is shown in FIG- URE 8, wherein clips B and C are of the FIGURE 1 type and clip A is of the FIGURE 3 (or FIGURE 6) type.

Clasps of this invention are applied through the use of: a clamping tool such as a forceps, through which they are placed in radial gripping positions around the lips of the uterine cervix. Preferably, jaw 10 (or 30) is introduced into the mouth of the cervix and its flat surf-ace is caused to lie upon the incised area to apply pressure as a pad on such surface. The taper or triangulation of jaw 10 (or 30) compensates for the inward taper of diameter of the endocervix and flare or divergence of jaw 12 (or 32) for the inward increase of diameter of the ectocervix, between which is the incised extremity area which has been conized. If the cervix is oblate instead of circular in cross-section some clips of both general types may be desirable as shown that is some with the relatively short tapered jaw and some with the relatively long tapered jaw. Another advantage of this practice is described hereinafter.

The clasps are applied after the cervix has been incised as in a conization operation to first seize the major bleeding points. Referring to FIGURE 8, three clasps are shown in position with other clasping positions indicated. The intermediate clasp A is at the six oclock position. Normally, other clasps would be placed at the 3-, 9- and 12- oclock positions, and then others intermediately to form a ring of clasps. Such intermediate clasps B and C lie respectively at the sides of clasp A. Their tapered jaws 10 in an actual application lie in close juxtaposition to the jaw of clasp A. In this way, by the installation of a sufficient number of clasps to encompass the cervix, pressure is applied substantially uniformly over the entire ringlike incised area. The application of pressure in this manner serves to hold the tissue apart as it heals and tends to avoid stricture of the mouth of the uterine cervix. Also slight spacing of the clasps permits drainage of the operative site as healing progresses.

Where the cervix is large and the annular, incised area is likewise of substantial dimension, it has been found desirable to use, in the manner shown in FIGURE 8, both the FIGURE 1 and the FIGURE 6 (or 3) clasps. Because of the extra length of the single pronged jaw 30 the same will extend inward a greater degree than is the case with jaw 10. This staggers or offsets the point ofengagement of the clasps in their side-by-side relationship in the cervix. Also by making the spatulate jaw 32 shorter in relation to the length of jaw 12 the engaging prongs of adjacent clasps likewise engage in offset relationship, thus distributing the points of engagement over larger area or surface.

By reliance upon the variables mentioned above, a surgeon may select and apply clasps that have a 10-, 14- or l8-day, or even longer, life in the patients body. Deterioration at the hinge progresses at all times. It will be apparent that, as the holding power of the clasps reduces, there is a release of pressure upon live tissue, which permits scar tissue growth and avoids its pressure necrosis. In time, the hinge bend 14 will be so deteriorated that the jaws become fully separated. It is usual, in connection with surgical conization, to make a post-operative examination during the first and second and following weeks, at which time the surgeon will normally remove the severed parts and useless clasps.

While the clasps or clips shown and described herein are of a size and shape desirable to accommodate. the bleeding problems attendant upon cervical conization it will be apparent that similar clasps may also be used in smaller sizes where tissue is removed by the bitebiopsy technique.

It will be understood that the foregoing descriptive disclosure, with the preferred and modified forms of the invention shown and described, is exemplary of the in vention. It is intended that such forms and variations and modifications of details of this invention that fall within the scope of the subjoined claims will be protected by this patent within the applicable doctrine of equivalents.

What is claimed is:

1. A cervical clamp comprising first and second elongated clamp arms having mutually opposed clamping faces extending lengthwise and widthwise of said arms,

flange members extending along the length of the longitudinal edges of each arm and smoothly curving therefrom to be directed away from the opposing arm,

at least one tissue penetrating element on each arm directed toward the opposing arm, hinge means unitary with said arms and interconnecting said arms at one end thereof with said arms projecting from said hinge means in divergent relationship,

said hinge means comprising a generally U-shaped portion having an inside tissue-engaging face forming a continuation of the clamping faces of said arms, said first arm being tapered convergently in width from said hinge means to the opposite end of said arm, whereby a plurality of said clamps may be placed at successive locations around the periphery of a conized cervix with the convergently tapered arms extending into the inwardly tapered cervical canal in side-by-side relationship, said hinge means being operable to maintain the arms of each clamp against separation to effect hemostasis of the cervix. 2. A cervical clamp comprising first and second elongated clamp arms having mutually opposed clamping faces extending lengthwise and widthwise of said arms, at least one tissue penetrating element on each arm directed toward the opposing arm,

hinge means unitary with said arms and interconnecting said arms at one end thereof with said arms projecting from said hinge means in diver-gent relationship, said hinge means comprising a generally U-shaped portion having an inside tissue-engaging face forming a continuation of the clamping faces of said arms, said first arm being tapered convergently in width from said hinge means to the opposite end of said arm, said second arm being tapered divergently in width from said hinge means to the opposite end of said arm, whereby a plurality of said clamps may be placed at successive locations around the periphery of a conized cervix with the convergently tapered arms extending into the inwardly tapered cervical canal in side-by-side relationship, said hinge means being operable to maintain the arms of each clamp against separation to effect hemostasis of the cervix. 3. A cervical clamp comprising first and second elongated clamp arms having mutually opposed clamping faces extending lengthwise and widthwise of said arms, hinge means unitary with said arms and interconnecting said arms at one end thereof with said arms projecting from said hinge means in divergent relationship,

said hinge means comprising a generally U-shaped portion having an inside tissue-engaging face forming a continuation of the clamping faces of said arms, said first arm being tapered convergently in width from said hinge means to the opposite end of said arm, said second arm being tapered divergently in width from said hinge means to the opposite end of said arm, a tissue penetrating element on the projecting end of said first arm,

a pair of tissue penetrating elements on the projecting end of said second arm and spaced apart transversely of such arm so as to lie on respectively opposite sides of the element on said first arm,

whereby a plurality of said clamps may be placed at successive locations around the periphery of a conized cervix with the convergently tapered arms extending into the inwardly tapered cervical canal in side-by-side relationship, said hinge means being operable to maintain the arms of each clamp against separation to efiect hemostasis of the cervix, 4. A cervical clamp comprising first and second elongated clamp arms of difierent lengths having mutually opposed clamping faces extending lengthwise and widthwise of said arms, flange members extending along the length of the longitudinal edges of each arm and smoothly curving therefrom to be directed away from the opposing arm, at least one tissue penetrating element on each arm directed toward the opposing arm, hinge means unitary with said arms and interconnecting said arms at one end thereof with said arms projecting from said hinge means in divergent relationship, said hinge means comprising a generally U-shaped portion having an inside tissue-engaging face forming a continuation of the clamping faces of said arms,

said first arm being tapered convergently in width from said hinge means to the opposite end of said arm,

whereby a plurality of said clamps may be placed at successive locations around the periphery of a conized cervix with the convergently tapered arms extending into the inwardly tapered cervical canal in side-byside relationship, said hinge means being operable to maintain the arms of each clamp against separation to elfect hemostasis of the cervix.

References Cited UNITED STATES PATENTS OTHER REFERENCES Andrews, E. W., M.D.: Absorbable Metal Clips as Substitutesin J.A.M.A., pp. 27828 1, July 28, 1917 RICHARD A. GAUDET, Primary Examiner. G. E. MCNEILL, Assistant Examiner, 

1. A CERVICAL CLAMP COMPRISING FIRST AND SECOND ELONGATED CLAMP ARMS HAVING MUTUALLY OPPOSED CLAMPING FACES EXTENDING LENGTHWISE AND WIDTHWISE OF SAID ARMS, FLANGE MEMBERS EXTENDING ALONG THE LENGTH OF THE LONGITUDINAL EDGES OF EACH ARM AND SMOOTHLY CURVING THEREFROM TO BE DIRECTED AWAY FROM THE OPPOSING ARM, AT LEAST ONE TISSUE PENETRATING ELEMENT ON EACH ARM DIRECTION TOWARD THE OPENING ARM, HINGE MEANS UNITARY WITH SAID ARMS AND INTERCONNECTING SAID ARMS AT ONE END THEREOF WITH SAID ARM PROJECTING FROM SAID HINGE MEANS IN DIVERGENT RELATIONSHIP, SAID HINGE MEANS COMPRISING A GENERALLY U-SHAPED PORTION HAVING AN INSIDE TISSUE-ENGAGING FACE FORMING A CONTINUATION OF THE CLAMPING FACES OF SAID ARMS, SAID FIRST ARM BEING TAPERED CONVERGENTLY IN WIDTH FROM SAID HINGE MEANS TO THE OPPOSITE END OF SAID ARM, WHEREBY A PLURALITY OF SAID CLAMPS MAY BE PLACED AT SUCCESSIVE LOCATIONS AROUND THE PERIPHERY OF A CONIZED CERVIX WITH THE CONVERGENTLY TAPERED ARMS EXTENDING INTO THE INWARDLY TAPERED CERVICAL CANAL IN SIDE-BY-SIDE RELATIONSHIP, SAID HINGE MEANS BEING OPERABLE TO MAINTAIN THE ARMS OF EACH CLAMP AGAINST SEPARATION TO EFFECT HEMOSTASIS OF THE CERVIX. 